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| Product NDC Code | 79753-051 | ||||
|---|---|---|---|---|---|
| Drug Name | Bare republic spf 30 mineral sunscreen citrus cooler |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SPRAY | ||||
| Application Number | M020 | ||||
| Labeler Name | COOLA, LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Zinc Oxide - 14.0%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions • Shake well. Apply liberally 15 minutes before sun exposure. Hold container 4 to 6 inches from skin to apply. Rub in. Do not spray directly on face. Spray onto hands and apply to face. • When properly used, mineral sunscreens will leave a whitish tint when first applied. • Reapply: • after 80 minutes of swimming or sweating • immediately afrer towel drying • at least every 2 hours • Sun Protection Measures . Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: • limit time in the sun, especially from: 10 a.m. -2 p.m. • wear long-sleeve shirts, pants, hats, and sunglasses • Children under 6 months: Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Water, Butyloctyl Salicylate, Shea Butter Ethyl Esters, Polyester-8, Bentonite, Octyldodecyl Oleate, Rubus ldaeus (Raspberry) Seed Oil, Daucus Carota Sativa (Carrot) Seed Oil, Vitis Vinifera (Grape) Seed Oil, Jojoba Esters, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Reticulata (Tangerine) Peel Oil, Citrus Limon (Lemon) Peel Oil, Mentha Piperita (Peppermint) Oil, Mimosa Tenuiflora Bark Extract, Me1hyl Dihydrobietate, Caprylyl Glycol, Microcrystalline Cellulose, Cetearyl Alcohol, Coco-Glucoside, C14-22 Alcohols, Tocopherol, Caprylohydroxamic Acid, Glycerin, Cellulose Gum, C12-20 Alkyl Glucoside
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses • Helps prevent sunburn • If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.
Purpose
Information about the drug product’s indications for use.Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Bare Republic SPF 30 Mineral Sunscreen Citrus Cooler Zinc Oxide LEMON OIL, COLD PRESSED PEPPERMINT OIL WATER TOCOPHEROL HYDROGENATED JOJOBA OIL, RANDOMIZED CAPRYLHYDROXAMIC ACID POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) CARROT SEED OIL CETOSTEARYL ALCOHOL GRAPE SEED OIL BUTYLOCTYL SALICYLATE METHYL DIHYDROABIETATE MICROCRYSTALLINE CELLULOSE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM BENTONITE RASPBERRY SEED OIL COCO GLUCOSIDE SHEA BUTTER ETHYL ESTERS GLYCERIN C14-22 ALCOHOLS OCTYLDODECYL OLEATE CAPRYLYL GLYCOL C12-20 ALKYL GLUCOSIDE ZINC OXIDE ZINC OXIDE MANDARIN OIL ORANGE OIL, COLD PRESSED MIMOSA TENUIFLORA BARK
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.1
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.May stain fabrics Protect this product from excessive heat and direct sun
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Call 760-940-2125
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur. For external use only Flammable : Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120° F. Do not use in the presence of a flame or spark, or while smoking. Do not use on damaged or broken skin When using this product keep away from face to avoid breathing in • Keep out of eyes. Rinse with water to remove. Apply outdoors. Avoid overspray as could cause surface to become slippery. Do not apply in windy conditions. Use in a well ventilated area. Stop use and ask doctor if skin rash occurs
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API